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At 030
At 030
Applanation tonometer
Documentation set
Copyright
©2020, Carl Zeiss Meditec AG, Jena
Trademarks
All trademarks mentioned in this document are the property of
their respective owners.
Contents
319300-9120-000-Inhalt0-GB-240320
Contents
319300-9120-000-Inhalt1-GB
AT 030
Applanation tonometer
Contents
1 Notes on the instructions for use ............................................................... 5
1.1 Product name .................................................................................................................... 5
1.2 Scope of application .......................................................................................................... 5
1.3 Purpose and storage of the documentation ...................................................................... 5
1.4 Questions and comments .................................................................................................. 5
1.5 Conventions in this document ........................................................................................... 5
1.5.1 Conventions in all text areas.......................................................................................................... 5
1.5.2 Conventions in a course of action.................................................................................................. 6
1.6 Applicable documents ....................................................................................................... 6
4 Installation ................................................................................................. 15
4.1 Installation safety .............................................................................................................. 15
4.2 General information .......................................................................................................... 15
4.3 Mounting the device on SL 800 slit lamp using the swivel-mounted tonometer holder on
the stereomicroscope or Fundus VarioView ...................................................................... 16
4.4 Mounting the device to the SL 120, SL 130 and SL 220 slit lamps using the swivel-
mounted tonometer holder behind the stereomicroscope................................................. 18
4.5 Mounting the device on SL 120, SL 130, SL 220, and ZEISS VISULAS laser slit lamps
using the fixed tonometer holder ...................................................................................... 20
5 Daily startup............................................................................................... 23
5.1 Preparation safety ............................................................................................................. 23
5.2 Measuring spherical corneal surfaces ................................................................................ 24
319300-9120-000-GA-GB-240320 3 / 60
Contents Instruction for use
AT 030
7 Maintenance .............................................................................................. 33
7.1 Metrological check ............................................................................................................ 33
7.2 Adjusting the swivel-mounted tonometer holder with square mounting interface
(version a).......................................................................................................................... 34
7.3 Adjusting the swivel-mounted tonometer holder with round mounting interface (version
b) ....................................................................................................................................... 39
7.4 Checking the device........................................................................................................... 44
8 Troubleshooting......................................................................................... 47
9 Technical specifications.............................................................................. 51
9.1 Compliance........................................................................................................................ 51
9.1.1 Directives with which the device is compliant ................................................................................ 51
9.1.2 Classification of the device ............................................................................................................ 51
9.2 Device data........................................................................................................................ 51
9.3 Dimensions and weights.................................................................................................... 52
9.4 Ambient requirements....................................................................................................... 52
10 Optional accessories................................................................................... 53
Glossary ..................................................................................................... 57
Index .......................................................................................................... 59
4 / 60 319300-9120-000-GA-GB-240320
Instruction for use 1 Notes on the instructions for use
AT 030 1.1 Product name
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1 Notes on the instructions for use Instruction for use
1.6 Applicable documents AT 030
6 / 60 319300-9120-000-GA-GB-240320
Instruction for use 2 Safety notes
AT 030 2.1 Intended user profile
2 Safety notes
Operating personnel
The device may only be operated by instructed and trained
personnel.
u Ensure that the operating personnel have been trained and
instructed.
u Ensure that the operating personnel have read and understood
the instructions for use.
u The instructions for use should be readily accessible to the
operating personnel at all times.
u To facilitate access for the entire operating personnel: If
necessary, request further copies of the instructions for use
from ZEISS.
u Define the required skills for handling the device and provide
information on who is authorized for which activities.
u Define rules for reporting errors and damage, and provide
information on these. Notification to manufacturers and
authorities [} 8]
u Regularly check compliance with the national laws and regula-
tions concerning accident prevention and occupational health.
319300-9120-000-GA-GB-240320 7 / 60
2 Safety notes Instruction for use
2.4 Measures and duties of the operator AT 030
Ambient conditions
u Make sure that the installation conditions and the operation of
the device comply with the surgical requirements:
• Low vibration
• Clean environment
• Avoid extreme mechanical loads
u Do not store or use this device in damp areas. Do not expose
the device to water splashes, dripping water or sprayed water.
u Ensure that no liquids can enter the device.
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Instruction for use 2 Safety notes
AT 030 2.5 Maintenance measures
Transport
u When assembling or transporting the AT 030 applanation
tonometer, the measuring element must be set to 2.0 using the
rotary knob. Only in this way the measuring arm with the
measuring prism holder will be at a defined position.
u Transport the device over long distances (e.g. move, return for
repair, etc.) only in original packaging or special return
packaging.
u Contact your dealer or ZEISS Service.
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Instruction for use 3 Description of the device
AT 030 3.1 Package check list
Manufacturer
Date of manufacture
SN Serial number
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3 Description of the device Instruction for use
3.3 Structure of the device AT 030
3
8
4
6
5 5
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Instruction for use 3 Description of the device
AT 030 3.4 Functional description
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Instruction for use 4 Installation
AT 030 4.1 Installation safety
4 Installation
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4 Installation Instruction for use
4.3 Mounting the device on SL 800 slit lamp using the swivel-mounted tonometer AT 030
holder on the stereomicroscope or Fundus VarioView
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Instruction for use 4 Installation
AT 030 4.3 Mounting the device on SL 800 slit lamp using the swivel-mounted tonometer
holder on the stereomicroscope or Fundus VarioView
2 A
Figure 2: Mounting the AT 030 to the SL 800 slit lamp with swivel-mounted tonometer holder
319300-9120-000-GA-GB-240320 17 / 60
4 Installation Instruction for use
4.4 Mounting the device to the SL 120, SL 130 and SL 220 slit lamps using the AT 030
swivel-mounted tonometer holder behind the stereomicroscope
18 / 60 319300-9120-000-GA-GB-240320
Instruction for use 4 Installation
AT 030 4.4 Mounting the device to the SL 120, SL 130 and SL 220 slit lamps using the
swivel-mounted tonometer holder behind the stereomicroscope
2 3
A 1
A
Figure 3: Mounting the AT 030 on ZEISS slit lamps with swivel-mounted tonometer holder behind the stereo-
microscope e.g. SL 120 (left) and SL 220 (right)
319300-9120-000-GA-GB-240320 19 / 60
4 Installation Instruction for use
4.5 Mounting the device on SL 120, SL 130, SL 220, and ZEISS VISULAS laser slit AT 030
lamps using the fixed tonometer holder
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Instruction for use 4 Installation
AT 030 4.5 Mounting the device on SL 120, SL 130, SL 220, and ZEISS VISULAS laser slit
lamps using the fixed tonometer holder
1 8
7
2
6
3 4 5
Figure 4: Mounting the AT 030 to ZEISS slit lamps using the fixed
tonometer holder
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Instruction for use 5 Daily startup
AT 030 5.1 Preparation safety
5 Daily startup
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5 Daily startup Instruction for use
5.2 Measuring spherical corneal surfaces AT 030
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Instruction for use 5 Daily startup
AT 030 5.4 Preparing for measurement
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5 Daily startup Instruction for use
5.5 Measurement with AT 030 AT 030
1 2
Action 1. Position the patient’s head in front of the slit lamp using the
height adjustment of the head rest so that the eyes are level
with the red marking of the head rest.
The patient’s head must be pressed firmly against the head
rest.
2. Insert the clean and disinfected measuring prism into the
measuring prism holder as far as it will go. Hold the measuring
prism holder while doing so. Make sure that the extensible
measuring arm does not collide with the front or back limit
position of the motion range.
NOTE! The measuring prism has a graduated scale. The
measuring prism holder has a white and a red index line.
Please note the corresponding angle adjustment when
measuring spherical and toric curved corneal surfaces (see
also Measuring spherical corneal surfaces [} 24] and Measuring
toric cornea surfaces [} 24]).
26 / 60 319300-9120-000-GA-GB-240320
Instruction for use 5 Daily startup
AT 030 5.5 Measurement with AT 030
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5 Daily startup Instruction for use
5.6 Conversion table for tonometer readings AT 030
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Instruction for use 5 Daily startup
AT 030 5.6 Conversion table for tonometer readings
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Instruction for use 6 Cleaning and disinfection
AT 030 6.1 Safety when cleaning and disinfecting the device
6.2 Cleaning
Only clean the outer surfaces of the AT 030. A cloth slightly
moistened (not dripping) with diluted detergent is recommended
for cleaning the casing.
319300-9120-000-GA-GB-240320 31 / 60
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Instruction for use 7 Maintenance
AT 030 7.1 Metrological check
7 Maintenance
Force [mN]
Tonometer holder
All tonometer holders are adjusted when delivered. With a viewing
magnification of 12x or 16x, the rear surface of the measuring
prism lies concentrically in the field of view of the eyepiece. In the
center of the motion range of the measuring arm the front surface
of the measuring prism is focused in the eyepiece.
319300-9120-000-GA-GB-240320 33 / 60
7 Maintenance Instruction for use
7.2 Adjusting the swivel-mounted tonometer holder with square mounting AT 030
interface (version a)
Preparation
Action u Mount the tonometer holder and AT 030 on the slit lamp.
u Put the AT 030 into the position for the right eyepiece.
u Set the eyepieces of the slit lamp to 0 D or your own correction
value.
u Move the AT 030 to the measuring position.
u Illuminate the measuring prism with the slit lamp projector
from the left to approx. 90°.
34 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.2 Adjusting the swivel-mounted tonometer holder with square mounting
interface (version a)
1 2
C 3
5
D
5 Alignment holes
1 2 3
5 4
5 Swivel arm
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7 Maintenance Instruction for use
7.2 Adjusting the swivel-mounted tonometer holder with square mounting AT 030
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Instruction for use 7 Maintenance
AT 030 7.2 Adjusting the swivel-mounted tonometer holder with square mounting
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7 Maintenance Instruction for use
7.2 Adjusting the swivel-mounted tonometer holder with square mounting AT 030
38 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.3 Adjusting the swivel-mounted tonometer holder with round mounting
interface (version b)
Preparation
Action u Mount the tonometer holder and AT 030 on the slit lamp.
u Put the AT 030 into the position for the right eyepiece.
u Set the eyepieces of the slit lamp to 0 D or your own correction
value.
u Move the AT 030 to the measuring position.
u Illuminate the measuring prism with the slit lamp projector
from the left to approx. 90°.
319300-9120-000-GA-GB-240320 39 / 60
7 Maintenance Instruction for use
7.3 Adjusting the swivel-mounted tonometer holder with round mounting AT 030
interface (version b)
7
3
4
2
C
1
6 5 D
7 Base plate
40 / 60 319300-9120-000-GA-GB-240320
Instruction for use 7 Maintenance
AT 030 7.3 Adjusting the swivel-mounted tonometer holder with round mounting
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7 Maintenance Instruction for use
7.3 Adjusting the swivel-mounted tonometer holder with round mounting AT 030
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Instruction for use 7 Maintenance
AT 030 7.3 Adjusting the swivel-mounted tonometer holder with round mounting
319300-9120-000-GA-GB-240320 43 / 60
7 Maintenance Instruction for use
7.4 Checking the device AT 030
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Instruction for use 7 Maintenance
AT 030 7.4 Checking the device
1 Test weight
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Instruction for use 8 Troubleshooting
AT 030
8 Troubleshooting
Action 1. The axis of the measuring prism must coincide with the normal
to the corneal surface. This is the case if the fluorescein
semicircles are symmetrical to the separating line.
The two fluorescein semicircles are visible in the center of the
eyepiece and touch each other at their inner edges.
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8 Troubleshooting Instruction for use
AT 030
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Instruction for use 8 Troubleshooting
AT 030
Incorrect pressure
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Instruction for use 9 Technical specifications
AT 030 9.1 Compliance
9 Technical specifications
9.1 Compliance
If modifications not authorized by the manufacturer are made to
the device, this declaration ceases to be valid.
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9 Technical specifications Instruction for use
9.3 Dimensions and weights AT 030
Weight 245 g
52 / 60 319300-9120-000-GA-GB-240320
Instruction for use 10 Optional accessories
AT 030
10 Optional accessories
• Swivel-mounted tonometer holder
• Fixed tonometer holder
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med
Use only accessories and spare parts which are approved by ZEISS
for this device. When using accessories and spare parts that are not
approved by ZEISS, safe operation of the device cannot be
guaranteed.
A current and complete list of accessories can be obtained from
your retailer.
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Instruction for use 11 Disposal of the device
AT 030
319300-9120-000-GA-GB-240320 55 / 60
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Instruction for use Glossary
AT 030
Glossary
D
D (diopter) is the unit of measurement of
the refractive power of optical systems.
kPa
Kilopascal: 1 kPA = 1000 Pa
mbar
Millibar: 1 mbar = 1 hPa = 100 Pa
MDD
Medical Device Directive
mm Hg
Millimeter of mercury column:
measurement of intraocular pressure
319300-9120-000-GA-GB-240320 57 / 60
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Instruction for use Index
AT 030
Index
A
Ambient conditions ................................... 8
D
Disposal
Electronics ............................................ 55
Packaging material................................ 55
I
Intended user profile ................................. 7
O
Operating personnel .................................. 7
P
Product modification ................................. 8
U
User profile................................................ 7
319300-9120-000-GA-GB-240320 59 / 60
Carl Zeiss Meditec AG
07745 Jena
Germany
Internet: www.zeiss.com/med
E-Mail: info.meditec@zeiss.com
319300-9120-000-GA-GB-240320
Contents
319300-9120-000-Inhalt2-GB
Instructions for use and disinfection of tonometer
measuring prisms
Addendum
Addendum Table of contents
Instructions for use and disinfection of
tonometer measuring prisms
Table of contents
1 Notes on the instructions for use ............................................................... 5
1.1 Scope of application .......................................................................................................... 5
1.2 Intended use of the document........................................................................................... 5
1.3 Questions and comments .................................................................................................. 5
1.4 Conventions in this document ........................................................................................... 5
1.4.1 Conventions in all text areas.......................................................................................................... 5
1.4.2 Conventions in a course of action.................................................................................................. 6
319300-9231-000-AddGA01-GB-240320 3 / 18
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Addendum 1 Notes on the instructions for use
Instructions for use and disinfection of 1.1 Scope of application
tonometer measuring prisms
319300-9231-000-AddGA01-GB-240320 5 / 18
1 Notes on the instructions for use Addendum
1.4 Conventions in this document Instructions for use and disinfection of
tonometer measuring prisms
6 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 2 Safety notes
Instructions for use and disinfection of 2.1 Ambient conditions
tonometer measuring prisms
2 Safety notes
319300-9231-000-AddGA01-GB-240320 7 / 18
2 Safety notes Addendum
2.5 Validated cleaning and disinfecting agents Instructions for use and disinfection of
tonometer measuring prisms
Cleaning agents
• Palmolive 0.08 %
Disinfectants
Product Concen- Exposure Rinsing
tration time
Hydrogen 3% 10 minutes Rinse with cold water
peroxide H2O2 for 5 minutes
8 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 2 Safety notes
Instructions for use and disinfection of 2.6 List of disinfectants with good material compatibility with ZEISS measuring
tonometer measuring prisms prisms
319300-9231-000-AddGA01-GB-240320 9 / 18
2 Safety notes Addendum
2.6 List of disinfectants with good material compatibility with ZEISS measuring Instructions for use and disinfection of
prisms tonometer measuring prisms
NaOCl 10 % x max.
(sodium hypo- 100 cycles of
chloride) 1h
H2O2 (hydrogen 3% x
peroxide)
Acrylan® 1)
x
Almyrol® 4% x
Bodedex forte 1% x
Bomix plus 2% x
Cidex® OPA 1)
x
1)
Dakin solution x
Deconex 53 2% x
Instrument
Deconex 53 Plus 4% x
Endo Septol FF 5% x
Gigasept ® AF 4% x
Gigasept ® AF 5% x
forte
Gigasept ® FF 8% x
NEW
Gigasept PAA 2% x
concentrate
Hibitane ® 0.5 % x
Jiaen 6 % 0.05 % x
"Yoshida"
Korsolex basic 5% x
10 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 2 Safety notes
Instructions for use and disinfection of 2.6 List of disinfectants with good material compatibility with ZEISS measuring
tonometer measuring prisms
Mucocit®-T 6% x
NU-CIDEX® 1)
x
PeraSafe® 1)
x
Peraxylens® 1)
x
Perfektan® active 2% x
Perfektan® TB 4% x
Sekusept® Activ 2% x
Sekusept® Activ 1)
x
NEU
Sekusept® forte S 3% x
Sekusept® PLUS 4% x
Stabimed® 2% x
Sterihyde® L 2% x
1)
Tristel DUO x
1)
Tristel Sporicidal x
Wipes
1)
Activated solution according to manufacturer's instructions
319300-9231-000-AddGA01-GB-240320 11 / 18
2 Safety notes Addendum
2.7 Service life Instructions for use and disinfection of
tonometer measuring prisms
Year
12 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 3 Cleaning and disinfection of reusable measuring prisms
Instructions for use and disinfection of 3.1 Manual cleaning steps
tonometer measuring prisms
319300-9231-000-AddGA01-GB-240320 13 / 18
3 Cleaning and disinfection of reusable measuring prisms Addendum
3.2 Disinfection steps Instructions for use and disinfection of
tonometer measuring prisms
Action 1. Remove the measuring prisms from the tonometer holder (a)
and clean under running water (drinking water quality) (recom-
mended time 60 seconds).
2. Clean the measuring body with a pH-neutral cleaning agent
until no more dirt is visible.
3. The cleaning agent must then be rinsed off well under running
water (drinking water quality)! (recommended time 60 seconds)
(b).
4. Dry the measuring prisms with a lint-free disposable cloth (c).
5. Perform visual checks for cleanliness and perfect working
condition.
6. Place the cleaned measuring prisms in the Desinset plastic tray
(d).
14 / 18 319300-9231-000-AddGA01-GB-240320
Addendum 3 Cleaning and disinfection of reusable measuring prisms
Instructions for use and disinfection of 3.3 Rinsing and storage
tonometer measuring prisms
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3 Cleaning and disinfection of reusable measuring prisms Addendum
3.3 Rinsing and storage Instructions for use and disinfection of
tonometer measuring prisms
a b c d
e f g h
i j k l
16 / 18 319300-9231-000-AddGA01-GB-240320
Empty page, for your notes
Carl Zeiss Meditec AG
07745 Jena
Germany
Internet: www.zeiss.com/med
E-Mail: info.meditec@zeiss.com
319300-9231-000-AddGA01-GB-240320
Empty page, for your notes
Carl Zeiss Meditec AG
07745 Jena
Germany
Internet: www.zeiss.com/med
E-Mail: info.meditec@zeiss.com
319300-9120-000-DokS-GB-240320